MedTrace Logo

Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects With Mild to Moderate Ulcerative Colitis

NCT02093663 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2021-06-09

Study results available
· View outcomes & findings →

Summary

To assess clinical response to MMX mesalamine/mesalazine between a low and high dose in children and adolescents aged 5-17 years with mild to moderate Ulcerative Colitis (UC) or who are in remission.

Conditions

Interventions

DRUG

MMX Mesalamine/Mesalazine (Low Dose)

Once daily, tablets - the amount depends on the participants weight; 900 milligram per day (mg/day) for participants weighing 18 kg to less than or equal to (\<=) 23 kilograms (kg); 1200 mg/day for participants weighing greater than (\>) 23 kg to \<= 35 kg; 1800 mg/day for participants weighing \> 35 kg to \<= 50 kg; 2400 mg/day for participants weighing \> 50 kg to \<= 90 kg.

DRUG

MMX Mesalamine/Mesalazine (High Dose)

Once daily, tablets - the amount depends on the participants weight;1800 mg/day for participants weighing 18 kg to \<= 23 kg; 2400 mg/day for participants weighing \> 23 kg to \<= 35 kg; 3600 mg/day for participants weighing \> 35 kg to \<= 50 kg; 4800 mg/day for participants weighing \> 50 kg to \<= 90 kg.

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Shire Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-12
Primary Completion
2018-11-28
Completion
2018-11-28

Countries

  • United States
  • Canada
  • Hungary
  • Israel
  • Poland
  • Slovakia
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02093663 on ClinicalTrials.gov